Isoflavones and Magnolia Extract in the Quality of Life in Menopausal Women

Menopause Clinical Trial

— ESTROCALVI  

Official title:

Study to Evaluate the Changes in Quality of Life in Menopausal Women After the Administration of Soy Isoflavones Combined With Magnolia Extract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805674
• Other study ID #: ESTROCALVI
• Status: Completed
• Phase: N/A
• First received: March 1, 2013
• Last updated: November 4, 2014
• Start date: March 2013
• Est. completion date: October 2013

Study information

• Verified date: November 2014
• Source: Rottapharm Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural symptoms, globally worsens the quality of daily life.

The improvement of the quality could be reached with adequate food supplements, named phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with estrogen-like and estrogen-antagonistic activity, which are active in the control of menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the psychological symptomatology also improving the quality of life.

Description:

Multicenter, observational, prospective, longitudinal study of clinical practice conducted in 10 gynecological centers.

The study will be conducted in patients with typical mild to moderate vasomotor symptoms and psycho symptoms such as mood disorders, or sleep, anxiety / depression, which do not require specific drug treatment.

Quality of life will be analyzed by the scale of Cervantes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 59 Years

Eligibility

Inclusion Criteria:

• Women with at least 12 months of amenorrhea

• Presence of 1 or more vasomotor symptoms as hot flushing, nocturnal sweating or palpitations

• One or more psychological symptoms as insomnia, irritability, anxiety, depressed mood. Also with concomitant symptoms of sexual area as reduction of libido and vaginal dryness.

• Women must give the informed consent

Exclusion Criteria:

• clinical history of medical or surgical pathologies that could affect the results of the study, including serious cardiovascular, metabolic, kidney or liver diseases

• Patients with the habit of eating soy foods or dietary supplements with soy extract

• patients diagnosed with breast or uterine mass (neoplasia hormone sensitive)

• patients that were treated with estrogens (HRT or phytoestrogens)in the 2 months before the beginning of the study.

• patients with treatment with antibiotics, antidepressant and/or anxiolytic products

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• isoflavones combined with magnolia
1 tablet/day duration: 12 weeks

Locations

Country	Name	City	State
Spain	Centro Médico Teknon	Barcelona
Spain	Somdex S.L.	Barcelona
Spain	Surgery of Dr. Sánchez Muñoz	Ciudad Real
Spain	Grupo hospitalario Quirón	Erandio	Vizcaya
Spain	Gabinete Médico Velazquez	Madrid
Spain	Clínica ginecológica Cecchini	Oviedo
Spain	Instituto Sevillano de Ginecología y Obstetricia	Sevilla
Spain	Surgery of Dr. Mahiques	Valencia
Spain	Surgery of Dr. Raga	Valencia
Spain	Centro Ginecológico Dr. García Pérez-Llantada SL	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Rottapharm Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the quality of life measured by the scale of Cervantes	The Cervantes scale is a Spanish validated questionnaire specific for measure the quality of life in menopausal women	baseline and 12 weeks	No
Secondary	Clinical changes in vasomotor symptomatology	In a semiquantitative scale of intensity the vasomotor, psychological and sexual symptomatology will be evaluated in each visit	baseline, 2, 4, 8 and 12 weeks	No